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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
St. Jude Medical, Inc.
177 e.county rd. b east
st paul, MN 55117
PMA NumberP920004
Supplement NumberS018
Date Received03/26/2002
Decision Date08/13/2002
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of a single sponge collagen plug. The device, as modified, will be marketed under the trade names vasoseal elite vhd or es device and is indicated for: "sealing the femoral arterial puncture site in patients who have undergone diagnostic and interventional catheterization procedures using an 8 french or smaller procedural sheath and using a retrograde approach. The vasoseal elite vhd/es device reduces time to hemostasis, and ambulation in patients who have undergone diagnostic and interventional catheterization procedures. In addition, the vasoseal elite vhd/es device reduces time to discharge in diagnostic patients receiving 5-6 french procedural sheaths. Vasoseal elite vhd/es device reduces time to hemostasis in interventional, patients, when immediate sheath removal is desired. " the vasoseal elite vhd device indications include the statement: "however, early ambulation in these patients has not been determined. ".